CarboClear Posterior Cervical Screw System

FDA UDI

Class II (US FDA UDI)

by Carbofix Orthopedics Ltd

Identity

Trade Name: CarboClear Posterior Cervical Screw System FDA UDI
Generic Name: Fluted surgical drill bit, single-use FDA UDI
Device Name: Drill bit for use with the CarboClear Posterior Cervical Screw System FDA UDI
Model / Reference: Drill Bit FDA UDI
Description: Drill bit for use with the CarboClear Posterior Cervical Screw System FDA UDI

Identifiers

Catalog Number: CS026 FDA UDI
Primary DI / UDI-DI: 07290117351161 FDA UDI
510(k) Number: K233989 FDA UDI
FDA Product Code: NKG FDA UDI
ODP FDA UDI
GMDN Term: Fluted surgical drill bit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3075 FDA UDI
888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 4.0 Millimeter FDA UDI

Category: Fluted surgical drill bit, single-use

CarboClear Posterior Cervical Screw System by Carbofix Orthopedics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K233989 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Carbofix Orthopedics Ltd

Sources (1)

FDA UDI ad0c138b-0b8f-4ac7-9513-7d8dfe23add4 37 fields · synced May 30, 2026